An interventional study of Ketamine and Placebo in Narcotic Use and Renal Transplant Donor of Left Kidney, sponsored by Stony Brook University. Terminated. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-14.
Sponsored by Stony Brook University · Not applicable, Interventional, and Treatment
Kidney donors represent healthy patients and their anticipated postoperative course should be uncomplicated and brief. This study looks to optimize the perioperative pain regimen of laparoscopic donor nephrectomy patients by minimizing or eliminating narcotics from the immediate post-operative period. Current postoperative standard of care after donor nephrectomy require narcotic analgesics. While narcotics are potent pain medications, they are often associated with complications including nausea, vomiting and dysfunction of the gastrointestinal tract causing prolonged complications.
The investigators seek to evaluate a peri-operative pain regimen limiting the usage of narcotics. This incorporates a perioperative analgesic course utilizing combination of an intravenous non-steroidal anti-inflammatory drug (NSAID), intravenous acetaminophen, and intravenous ketamine. All three have been demonstrated to be effective for the control of perioperative pain while decreasing narcotics use.
Prior to surgery, participants will be consented and randomly assigned to receive the standard of care perioperative pain management using intravenous narcotics as a patient-controlled analgesia (PCA) by itself plus placebo or along with the new protocol. The study will demonstrate it the new protocol will limit or eliminate the need for narcotics as a patient-controlled dose during the postoperative period.
Upon discharge from the hospital, patients will be followed in clinic and via home questionnaires annually for 5 years to evaluate satisfaction, renal function and quality of life.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 56 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Stony Brook University is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 10 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this group will receive ketamine, morphine PCA and caldolor for pain control
Drug: Ketamine
Patients in this group receive placebo, morphine PCA, and caldolor for pain control
Other: Placebo
Length of hospital stay
length of stay after surgery
Time frame: number of days immediately after the surgery
post surgical complication rates
Time frame: 30 day
postoperative renal function (serum creatinine)
Time frame: up to 2 years after intervention
amount of narcotic pain medication use
Time frame: starting immediately after the surgery, during the inpatient time period
postoperative nausea
Time frame: number of patients reporting postoperative nausea during inpatient time period
return of bowel function (passage of flatus)
Time frame: the number of days after surgery at which return of bowel function is achieved
date of postoperative ambulation
Time frame: reported during inpatient time period
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Stony Brook University